Minimizing and Managing Lead Complications. Eric Buch MD Assistant Professor of Medicine Director, Specialized Program for Atrial Fibrillation

Transcription

1 Minimizing and Managing Lead Complications Eric Buch MD Assistant Professor of Medicine Director, Specialized Program for Atrial Fibrillation

2 Topics History of lead management Surveillance of implanted leads Managing lead complications Safe and effective lead extraction Preventing lead complications

3 Lead Management History Lead complications have occurred since the first use of implanted cardiac devices Removing chronically implanted leads using simple manual traction was associated with high rate of failure and serious complications (vascular or cardiac avulsion, tamponade, death) Therefore, extraction was only undertaken in extreme circumstances, such as sepsis

4 Buck s Traction for Lead Extraction Weights attached to externalized portion of lead using pulley Allowed constant application of gentle traction for hours-days But success rate still low, required prolonged bed rest, and infection often worsened

5 Maytin, US Cardiology 2009 Lead Management History

6 Lead Management History With the development of more specialized tools in the 1980s, especially telescoping sheaths and locking stylets, lead extraction became safer and more effective A major impetus for lead extraction came with the Telectronics Accufix lead, which was recalled in November 1994 after 2 deaths and 2 injuries were reported from fracture and protrusion of the J-shaped retention wire

7 Telectronix Accufix J Wire Protrusion Cooper, Medtronic Fellows Course 2009

8 Telectronics Accufix In the worldwide registry of ~35,000 patients with Accufix leads, a total of 40 injuries and 6 deaths were reported Over 5000 of these leads were extracted prophylactically, with 0.9% risk of fatal or lifethreatening complications and 4.3% risk of major complications 16 patients died during extraction Kay, Circulation 1999

9 Weighing the Risks and Benefits With longer duration of implant, risks of extraction outweighed risks of lead fracture Illustrates need to consider both risks and benefits of extraction Kay, Circulation 1999

10 Monthly Volume of Accufix Extraction After initial rush to extract leads led to complications and deaths, many centers adopted a less aggressive approach Cinefluoroscopic surveillance allowed for extraction only of damaged or dangerous leads Kawanishi, PACE 1998

11 Surveillance of Implanted Leads Medtronic Sprint Fidelis leads were recalled on 10/15/2007 due to higher than expected rate of conductor fractures The vast majority of fractures affected the anode or cathode, resulting in increased pacing impedance, oversensing leading to inhibition of pacing or inappropriate shocks, and occasionally failure to pace Occasional high-voltage conductor fractures were also seen, which could result in failure to defibrillate

12 Sprint Fidelis Lead Survival According to MDT database, 91-93% survival at 5 yrs

13 Sprint Fidelis Lead Survival Some analyses suggest that failure curve is increasing in an exponential, rather than liner, fashion Hauser, Heart Rhythm 2009

14 Maisel, Circulation 2008 All Leads Have a Failure Rate

15 Kleeman, Circulation 2007 All Leads Fail

16 Predictors of Lead Failure Higher risk if female, young, multiple leads Kleeman, Circulation 2007

17 Detecting Lead Failure: Remote Monitoring Remote monitoring can detect signs of lead failure, and alert clinician and patient, even between scheduled visits to the device clinic Maisel, Circulation 2008

18 Early Signs of Lead Dysfunction Can have normal impedance, R wave, capture threshold But EGM shows noise (nonphysiologic intervals) Dorwarth, JCE 2003

19 Clinical Presentation of ICD Lead Failure N=31 cases Dorwarth, JCE 2003

20 Software Algorithm for Lead Surveillance Lead-integrity algorithm is triggered by oversensing (intervals <130 ms) and increased lead impedance Once triggered, the number of intervals to detect (NID) a tachycardia episode is automatically extended to 30/40 Since most noise episodes are nonsustained, inappropriate therapy is aborted in most cases Swerdlow, Circulation 2008

21 Software Algorithm for Lead Surveillance Swerdlow, Circulation 2008

22 Software Algorithm for Lead Surveillance Swerdlow, Circulation 2008

23 Canadian Study: 5.3% Major Complications Gould, JAMA 2006

24 Weighing the Risks of Lead Extraction Maytin, US Cardiology 2009

25 Maytin, Circ Arrhyth 2010 Data on Lead Extraction

26 LExICon Study: 6.2% Major Complications Wazni, JACC 2008

27 Sprint Fidelis Extraction: 100% Success Maytin, JACC 2010

28 Lead Extraction HRS/AHA Consensus Statement Heart Rhythm 2009

29 Lead Extraction Indications Infected Class I All patients with definite CIED system infection, as evidenced by valvular endocarditis, lead endocarditis or sepsis. All patients with CIED pocket infection as evidenced by pocket abscess, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system. All patients with valvular endocarditis without definite involvement of the lead(s) and/or device. Patients with occult gram-positive bacteremia (not contaminant). Comments Same as NASPE 2000 Now Class I instead of Class II New New Wilkoff, Heart Rhythm 2009

30 Lead Extraction Indications Sterile Indication Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads. Lead removal is recommended in patients with leads that, due to their design or their failure, may pose an immediate threat to the patients if left in place (e.g., Telectronics ACCUFIX J wire fracture with protrusion). Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery). Class I I I Wilkoff, Heart Rhythm 2009

31 Lead Extraction Indications Sterile Indication Reasonable in patients with ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead, when there is no contraindication for using the contralateral side. Reasonable in patients if a CIED implantation would require more than 4 leads on one side or more than 5 leads through the SVC. May be considered at the time of an indicated CIED procedure, in patients with non-functional leads, if contraindications are absent. May be considered in patients with leads that are functional but not being used. Not indicated in patients with functional but redundant leads if patients have a life expectancy of less than one year. Class IIa IIa IIb IIb III Wilkoff, Heart Rhythm 2009

32 Establishing a Lead Extraction Program Build the proper team Primary operator, CT surgeon, Anesthesiologist, fluoroscopy operator, scrub and circulating assistants, echocardiographer Acquire the necessary equipment Locking stylets, snares, mechanical sheaths, powered sheaths Put someone in charge: director and coordinator Learn the techniques (course, simulator, visit) Plan, train, practice for emergencies Wilkoff, HRS Annual Meeting 2010

33 Institutional Requirements for Lead Extraction Center must have accredited for cardiac catheterization and cardiac surgery CT surgeon, cardiac surgery team, and equipment must be immediately available With SVC tear, delays of over 5-10 minutes to heart access often result in procedural death Available operating room, hybrid room, or catheterization laboratory with adequate fluoroscopy, capable of supporting emergent cardiac surgery Wilkoff, HRS Annual Meeting 2010

34 Prepare the Patient for Lead Extraction Preoperative CXR (number, type, position of leads), TEE (vegetation size, PFO), device and lead history, device interrogation Sterile prep from knees to jaw Femoral venous and arterial access with continuous arterial pressure monitoring Type and cross 4U PRBCs Temporary transvenous pacer if necessary Continuous echocardiographic monitoring All equipment immediately available for pericardiocentesis, sternotomy, CPB

35 Cooper, Medtronic Fellows Course 2009 Be Prepared

36 Lead Extraction for Device Infection Courtesy Noel Boyle Complete removal of device and leads is recommended unless infection only involves skin Infections involving the device pocket are almost always intravascular and cannot be cured without extraction of leads Occult gram-positive bacteremia is another indication for extraction

37 Lead Extraction for Device Infection

38 Reimplantation After Device Infection Carefully consider device indication in some series 30-50% of devices were not required New device should be on contralateral side No evidence of intravascular involvement: wait at least 72 hours Positive blood cultures without endocarditis: wait until blood or lead tip cultures are negative for at least 72 hours Endocarditis or lead vegetation: after 2-6 weeks of appropriate antibiotic therapy; if reimplantation cannot be delayed, consider epicardial leads or surgical debridement

39 Pacing-Dependent Patients Cooper, Medtronic Fellows Course 2009

40 What Makes Lead Extraction So Difficult? Venous entry Lead fibrosis Innominate SVC RA RA tip RV RV tip

41 Principles of Lead Extraction: Counterpressure Verma Heart Rhythm 2004

42 Principles of Lead Extraction: Countertraction Verma Heart Rhythm 2004

43 Lead Extraction Tools: Locking Stylets Unlocked Locked

44 Lead Extraction Tools: Telescoping Sheaths Maytin, US Cardiology 2009

45 Tools for Lead Extraction: Mechanical Sheaths

46 Lead Extraction Tools: Powered Sheaths Spectranetics Inc.

47 Tools for Lead Extraction: Powered Sheaths Jamil Aboulhosn MD Spectranetics Inc

48 Lead Extraction Tools: Femoral Snares

49 Lead Extraction Tools: Lead Extender

50 Challenges of Lead Extraction Sites of Lead Binding Long sheath Scar tissue Lead tip Peter H Belott MD

51 Challenges of Lead Extraction Sites of Lead Binding Spectranetics Inc

52 Spectranetics Inc. Technique of Lead Extraction

53 Spectranetics Inc. Technique of Lead Extraction

54 Spectranetics Inc. Technique of Lead Extraction

55 Spectranetics Inc. Technique of Lead Extraction

56 Relative Contraindications to Transvenous Lead Extraction Visible calcification of lead within SVC or RA Patient too frail or with too many comorbidities to tolerate emergent thoracotomy Limited patient life expectancy (retained sterile lead unlikely to pose significant risk) Known anomalous course of lead (extravascular) ICD proximal coil forms right radiographic border of mediastinum on PA chest film

57 Noel G Boyle MD At the End of the Case

58 Preventing Lead Complications: Use Good Surgical Technique Meticulous attention to sterility, Abx prophylaxis Avoid medial venous puncture (subclavian crush) use axillary or cephalic instead No sharp bends in leads at suture sleeve tiedown or in pocket Tie down only on sleeves (not bare leads) and avoid excessive force Consider single-coil ICD leads, especially in younger patients Henrikson, Heart Rhythm 2008

59 Preventing Lead Complications: Upgrade Wisely Replacement without lead revision Replacement with lead revision Poole, Circulation 2010

60 Preventing Lead Complications: Choose the Right Device Higher capacity battery added 5cc and 11g to ICD Increased longevity by average 2.3 years Hauser, JACC 2005

61 Summary With increasing number of implanted cardiac devices and increased longevity of patients, lead failure and infections will occur more frequently Lead surveillance and home monitoring can detect lead failures before they result in major complications Each lead failure should be considered as a unique case; patient and physician should decide together on best course of action Modern tools have helped make lead extraction safe and effective in experienced centers

62 THANK YOU